RecallRadar

FDA Device recall Z-0277-2016

Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93

On 2015-11-25 the FDA classified a Class II recall of Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93 by Teleflex Medical, citing the defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insert….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0277-2016
ClassificationClass II
Statusterminated
Initiated2015-10-14
Published2015-11-25
Last updated2026-09-13 11:53 UTC
CompanyTeleflex Medical
DistributionUS

Product

Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93. To provide an access port into the peritoneal cavity.

Reason

The defective component can cause gas leakage through the device. This can result in loss of pneumoperitoneum, potentially necessitating removal of the defective device and insertion of another device.

Identifiers

code_infoLot Numbers - 73A1500175, 73A1500306, 73B1500116, 73B1500418

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0277-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.